Medtronic recalls specific software versions of CareLink SmartSync Patient Connector Model 24967 due to a risk of unintended high-voltage therapy delivery during induction tests. Affected units may not properly cancel high-voltage treatments if the Abort button fails to stop the test.
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
Medtronic is recalling CareLink SmartSync Patient Connector Model 24967 with certain software versions because a flaw in the Abort button could prevent users from canceling high-voltage therapy during induction tests. This risk means users might not be able to stop a potentially harmful treatment if they need to abort the test.
The software issue causes the Abort button to stop the test prematurely in older versions, limiting the time window for users to cancel high-voltage therapy during induction tests. This could result in unintended high-voltage therapy delivery if the user needs to abort the test but the button fails to stop the process.
Patients using Medtronic CareLink SmartSync Patient Connector Model 24967 with the listed software versions are affected. Those with pacemakers or similar medical devices that use this connector are at the highest risk.
Check if your CareLink SmartSync Patient Connector has Model Number 24967 and the listed software versions (D00U003 to D00U012). The product was sold with specific software updates between 2020 and 2023.
Identify your software version by checking the device settings or documentation for the specific software model numbers listed in the recall.
Update to the latest software version (D00U012) or contact Medtronic for a software update if your device is affected.
The recall addresses a potential risk where the Abort button might not stop high-voltage therapy during induction tests, but it does not cause immediate harm. Affected users should update software to prevent this issue.
Check if your CareLink SmartSync Patient Connector has Model Number 24967 and the specific software versions listed in the recall (D00U003 to D00U012).
No, you do not need to stop using the device immediately. Updating the software resolves the issue, so continued use is safe after the update.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2168-2025 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2168-2025 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
